NDA 20151, held by Wyeth Pharms Inc. Venlafaxine Hydrochloride.
As of Nov 13, 2026, NDA 20151 (Effexor), held by Wyeth Pharms Inc, was first approved by FDA on Dec 28, 1993, with 52 approved supplements and 0 published complete response letters.
| May 5, 2004 | Supplement 24Efficacy (new indication or use) · Standard review | Approved | |
| May 2, 2001 | Supplement 17Efficacy (new indication or use) · Standard review | Approved | |
| May 2, 2001 | Supplement 18Efficacy (new indication or use) · Standard review | Approved | |
| Dec 28, 1993 | Original applicationNew molecular entity · Standard review | Approved | None posted |
| EffexorEQ 12.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Venlafaxine Hydrochloride | DiscontinuedReference drug |
| EffexorEQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Venlafaxine Hydrochloride | DiscontinuedReference drug |
| EffexorEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Venlafaxine Hydrochloride | DiscontinuedReference drug |
| EffexorEQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Venlafaxine Hydrochloride | DiscontinuedReference drug |
| EffexorEQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Venlafaxine Hydrochloride | DiscontinuedReference drug |
| EffexorEQ 37.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Venlafaxine Hydrochloride | DiscontinuedReference drug |
| Dec 12, 2012 | Supplement 31Labeling · Standard review | Approved | |
| Dec 12, 2012 | Supplement 55Labeling · Standard review | Approved | |
| Dec 12, 2012 | Supplement 58Labeling · Standard review | Approved | |
| Dec 12, 2012 | Supplement 60Labeling · Standard review | Approved | |
| May 2, 2012 | Supplement 59Labeling · Standard review | Approved | |
| Jan 6, 2010 | Supplement 56Labeling · Standard review | Approved | |
| Jan 6, 2010 | Supplement 57Labeling · Standard review | Approved | |
| Nov 9, 2009 | Supplement 53Labeling · Standard review | Approved | |
| Jan 30, 2009 | Supplement 54Labeling · Standard review | Approved | |
| May 23, 2008 | Supplement 51Labeling · Standard review | Approved | |
| Feb 11, 2008 | Supplement 52Labeling · Standard review | Approved | |
| Feb 7, 2008 | Supplement 50Labeling · Standard review | Approved | None posted |
| Jan 30, 2008 | Supplement 41Labeling · Standard review | Approved | |
| Sep 20, 2007 | Supplement 47Labeling · Standard review | Approved | |
| Sep 20, 2007 | Supplement 49Labeling · Standard review | Approved | |
| Aug 1, 2007 | Supplement 33Labeling · Standard review | Approved | |
| Aug 1, 2007 | Supplement 46Labeling · Standard review | Approved | |
| Feb 7, 2007 | Supplement 43Labeling · Standard review | Approved | |
| Oct 20, 2006 | Supplement 45Labeling · Standard review | Approved | |
| Sep 14, 2006 | Supplement 44Labeling · Standard review | Approved | |
| Feb 24, 2006 | Supplement 34Labeling · Standard review | Approved | |
| Jan 12, 2006 | Supplement 38Labeling · Standard review | Approved | |
| Jan 12, 2006 | Supplement 39Labeling · Standard review | Approved | |
| Feb 18, 2005 | Supplement 35Labeling · Standard review | Approved | |
| May 13, 2004 | Supplement 30Labeling · Standard review | Approved | |
| May 13, 2004 | Supplement 32Labeling · Standard review | Approved | |
| May 13, 2004 | Supplement 28Labeling · Standard review | Approved | |
| May 5, 2004 | Supplement 24Efficacy (new indication or use) · Standard review | Approved | |
| Apr 8, 2004 | Supplement 29Labeling · Standard review | Approved | |
| Mar 19, 2004 | Supplement 27Labeling · Standard review | Approved | |
| Jan 31, 2003 | Supplement 16 | Approved | |
| Jan 31, 2003 | Supplement 19 | Approved | |
| Jan 31, 2003 | Supplement 20 | Approved | |
| Jan 31, 2003 | Supplement 21 | Approved | |
| Jan 31, 2003 | Supplement 22 | Approved | |
| Jan 31, 2003 | Supplement 23 | Approved | |
| Jan 31, 2003 | Supplement 25 | Approved | |
| May 2, 2001 | Supplement 17Efficacy (new indication or use) · Standard review | Approved | |
| May 2, 2001 | Supplement 18Efficacy (new indication or use) · Standard review | Approved | |
| Jul 20, 2000 | Supplement 11Labeling · Standard review | Approved | None posted |
| Jul 20, 2000 | Supplement 13Labeling · Standard review | Approved | None posted |
| Jul 20, 2000 | Supplement 15Labeling · Standard review | Approved | None posted |
| Mar 3, 2000 | Supplement 14Labeling · Standard review | Approved | None posted |
| Oct 4, 1999 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Dec 9, 1998 | Supplement 6Labeling · Standard review | Approved | None posted |
| Dec 9, 1998 | Supplement 7Labeling · Standard review | Approved | None posted |
| Dec 9, 1998 | Supplement 8Labeling · Standard review | Approved | None posted |
| Dec 9, 1998 | Supplement 9Labeling · Standard review | Approved | None posted |
| Jun 25, 1996 | Supplement 5Labeling · Standard review | Approved | None posted |
| Nov 28, 1994 | Supplement 2Labeling · Standard review | Approved | None posted |
| Nov 16, 1994 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Nov 16, 1994 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Dec 28, 1993 | Original applicationNew molecular entity · Standard review | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
